Kornimate/medical-research-clean huggingface dataset:
renal function in patients submitted to myocardial revascularization surgery

Conditions: Coronary Disease

Summary: acute renal insufficiency (ari) represents a frequent and serious complication in patients submitted to cardiac surgery, and is associated with increases in time of hospitalization, costs, morbidity and mortality. its incidence varies from 3.5% to 31%. the present study aims to evaluate renal function and oxidative stress in patients submitted to revascularization surgery with extracorporeal circulation (ecc), comparing targeted venous anesthesia controlled with propofol and inhalational anesthesia with isoflurane.

acute renal insufficiency (ari) represents a frequent and serious complication in patients submitted to cardiac surgery, and is associated with increases in time of hospitalization, costs, morbidity and mortality. its incidence varies from 3.5% to 31%. the present study aims to evaluate renal function and oxidative stress in patients submitted to revascularization surgery with ecc, comparing targeted venous anesthesia controlled with propofol and inhalational anesthesia with isoflurane.the study will be conducted at the botucatu medical school (fmb) and will analyze 60 patients, divided into two randomized groups, submitted to revascularization surgery of the myocardium with ecc. the researcher responsible for data collection from patients will not have knowledge of the type of anesthesia being delivered to the patient.blood samples will be collected by central venous access for dosing of troponin i, troponin t, ckmb, mda, creatinine, urea, albumin and cystatin c.renal function will be evaluated by serum cystatin c and creatinine and the estimated glomerular filtration rate (gfr). gfr will be measured by means of serum cystatin c (larsson's formula) and by serum creatinine through the cockcroft-gault formula (cg) and by the mdrd formula (modification of diet in renal disease).markers of renal tubular function will be dosed in the urine, including: alkaline phosphatase, γ - glutamyltransferase(γ-gt), β 2 microglobulin, creatinine and urinary cystatin c.

Eligibility criteria:
inclusion criteria: * both sexes, * aged from 18 to 75 years, * submitted to revascularization surgery of the myocardium * extracorporeal circulation, * who had consented to participation by signing the terms of free and clear consent. exclusion criteria: * history of hepatic or renal dysfunction, * history involving acute myocardial infarct * patients that made use of vitamin c and e; * patients presenting other cardiac pathologies (valvular, congenital, corrected or not in the same operational act).

Keywords: isoflurane; propofol renal functions tests cardiovascular tests revascularization surgery of the myocardium extracorporeal circulation
airflo2 treatment for hypoxia and/or tachypnea in patients with covid-19

Conditions: Corona Virus Infection; Respiratory Rate; Hypoxia; Covid19

Summary: the study is an unblinded, randomized, controlled trial for use of the airflo2 device for patients admitted to duke hospital with covid-19 and tachypnea (rr \>20 breaths/min) and/or hypoxia (oxygen saturation \<94% on room air or requiring supplemental oxygen at baseline).

the aim of the study is to determine whether the use of the airflo2 device can improve hypoxia as measured by change between partial pressure of arterial oxygen to fraction of inspired oxygen- p:f ratio (pao2:fio2) and repeat p:f ratio between 1 to 6 hours after using the device. this is an unblinded, randomized, controlled trial for use of the airflo2 device for patients admitted to duke hospital with covid-19 and tachypnea (rr \>20 breaths/min) and/or hypoxia (oxygen saturation \<94% on room air or requiring supplemental oxygen at baseline). groups will be analyzed by intention to treat. per-protocol analyses will also be performed. descriptive statistics will be reported for the overall subject population, and for the two groups.

Eligibility criteria:
inclusion criteria: * adults ≥18 years of age with confirmed covid-19 infection * patient must be able to complete consent and hold mask * baseline room air oxygen saturation \<94% or new supplemental oxygen requirement at presentation or patient on supplemental oxygen at baseline and requiring up-titration of oxygen setting * patient in negative pressure room * patient must have access to an internet-connected device exclusion criteria: * tracheostomy * history of pneumothorax or known bullous lung disease * recent cataract surgery * patient receiving niv (noninvasive ventilation) or hfnc (high flow nasal cannula) * patient receiving mechanical ventilation * delirium
detection of c-peptide in youth with longstanding type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: background type 1 diabetes is characterized by pancreatic beta-cell destruction and an inability to synthesize insulin. connecting peptide (c-peptide) is formed from the same precursor as insulin and is produced in equimolar amounts as insulin. there are several clinical trials currently being performed to explore the possibility of beta-cell preservation or regeneration. most children are not eligible for these trials because it is often presumed that c-peptide levels will decrease and become undetectable after years of having type 1 diabetes. several studies in the adult population have demonstrated that c-peptide may remain measureable in patients who have had diabetes for up to 50 years after diagnosis. recently, it was demonstrated that 10% of adult patients who have had type 1 diabetes for 31-40 years have measureable levels of serum c-peptide if measured with an ultrasensitive assay. the levels were lower in patients who had diabetes for a longer time. this pattern was also demonstrated in the diabetes control and complications trial (dcct) and nhanes trial. no studies have been performed exclusively in pediatric patients hypothesis the investigators hypothesize that c-peptide should be detectable in the sera of pediatric patients who have had type 1 diabetes for greater than 1 year and as far out as \> 20 years after diagnosis. the investigators also hypothesize that since their patient population has had diabetes for less time as compared to adults, the levels of c-peptide should be higher than reported for adults and that a greater proportion of patients in the pediatric population will have detectable c-peptide levels as compared to adults.

1) objectives: 1. to determine if c-peptide is detectable in the sera of children that have had type 1 diabetes for more than 1 year using an ultrasensitive assay. 2. to correlate c-peptide levels with duration since diagnosis, current age, antibody titers at diagnosis, hemoglobin a1c, total daily insulin dosage. 3. to determine responsiveness of residual c-peptide to mixed-meal testing.

Eligibility criteria:
inclusion criteria: * male or female * 1-25 years of age * have had type 1 diabetes for more than 1 year. exclusion criteria: * does not meet inclusion criteria * foster children * patients without primary caregiver * pregnant

Keywords: c-peptide type 1 diabetes
pelvic girdle pain in pregnant women

Conditions: Gestational Diabetes; Pelvic Girdle Pain; Pregnant Woman

Summary: pelvic girdle pain and gestational diabetes mellitus are experienced in similar trimesters of pregnancy. the aim of this study is to examine the effect of gestational diabetes mellitus on the occurrence of pelvic girdle pain and the severity of symptoms of pelvic girdle pain in pregnant women.


Eligibility criteria:
inclusion criteria: pregnant women diagnosed with gdm in the 2nd and 3rd trimesters pregnant women without gdm diagnosis in 2nd and 3rd trimester first pregnancy second or third pregnancy 20-40 years old exclusion criteria: diabetes mellitus before pregnancy the presence of an orthopedic or neurological problem that may cause musculoskeletal disorder and biomechanical sequence deviations from normal pre-pregnancy chronic lumbar-pelvic pain description history of spine, pelvis or lower extremity surgery or fracture in the past 6 months

Keywords: gestational diabetes mellitus, pregnancy pelvic girdle pain
a 12-week titrate study to evaluate safety, tolerability and pharmacodynamics of pf-06882961 in adults with type 2 diabetes mellitus and in non-diabetic adults with obesity

Conditions: Diabetes; Obesity

Summary: this study will assess tolerability, safety, and pharmacodynamics (pd) of twice daily (bid) administration of pf- 06882961 in adult participants with type 2 diabetes mellitus (t2dm) who are treated with metformin and in non-diabetic adults with obesity


Eligibility criteria:
inclusion criteria: * male or female participants between the ages of 18 and 75 years, inclusive, at visit 1 (screening). exclusion criteria: * diagnosis of type 1 diabetes mellitus or secondary forms of diabetes. * history of myocardial infarction, unstable angina, arterial revascularization, stroke, new york heart association functional class ii iv heart failure, or transient ischemic attack within 6 months of screening (visit 1). * participants with a known medical history of active liver disease (other than non alcoholic hepatic steatosis), including chronic active hepatitis b or c, or primary biliary cirrhosis. * history of major depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years. * any lifetime history of a suicide attempt.
pramipexole conversion to ropinirole controlled release (cr)

Conditions: Parkinson Disease

Summary: a conversion study of mirapex (pramipexole) to requip (ropinirole) controlled release (cr) in patients with parkinson's disease to determine the appropriate conversion ratio and side effects related to the drug.

three different arms will be used in this study. each of the three cohorts will be treated sequentially. each participant will be taking mirapex for pd and will be converted to requip cr by 1 of 3 conversion factors (mg:mg): 1:3, 1:4 and 1:5 from mirapex to once a day requip cr. the first five subjects of each cohort will have their initial dose administered in the clinic and be monitored for orthostatic changes. assessments of motor function before and after conversion will be done.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson disease * currently taking pramipexole * never have taken requip cr exclusion criteria: * can not have significant adverse effects to standard requip * can not have atypical pd due to drugs, metabolic disorders, encephalitis or degenerative diseases * can not have unstable medical conditions * can not be taking concurrent monoamine oxidase inhibitors except for selegiline (10mg per day or less) * female patients of childbearing potential must be using an effective method of contraception. * can not be pregnant or lactating. this may not be a complete list; there may be additional criteria which may apply.

Keywords: pd parkinson's
evaluation of taihao breast ultrasound diagnosis software rn-ces descartes

Conditions: Breast Cancer; Breast Diseases

Summary: a standard of truth "sot" is determined based on the interpretation results of the case data by interpretation experts, and the sot is compared with the detection results of this program's function for detecting suspected breast cancer (cade function). estimate the detectability of the cade function by comparing.


Eligibility criteria:
inclusion criteria: * female patients aged 20 to 69, including those with and without breast lesions. exclusion criteria: * have a pacemaker or prosthetic valve. * a post-surgery follow-up patient.
a gene therapy study for homozygous familial hypercholesterolemia (hofh)

Conditions: Homozygous Familial Hypercholesterolemia (HoFH)

Summary: this first-in-human study is intended to evaluate the safety and preliminary effectiveness of aav (adeno-associated virus)-based liver-directed gene therapy in the treatment of adults with homozygous familial hypercholesterolemia (hofh).

homozygous familial hypercholesterolemia (hofh) is a rare genetic metabolic disorder characterized by absent or severely reduced capacity to catabolize circulating ldl (low density lipoprotein) particles by the hepatic ldl receptor. as a consequence, hofh subjects present abnormal total plasma cholesterol (ldl-c) levels, resulting in severe atherosclerosis often leading to early onset of cardiovascular disease. early initiation of aggressive treatment for these patients is therefore essential. unfortunately, despite existing therapies, treated ldl-c (low density lipoprotein cholesterol) levels could remain well above acceptable levels. thus, the functional replacement of the defective ldlr via aav-based liver-directed gene therapy may be a viable approach to treat this disease and improve response to current lipid-lowering treatments. this first-in-human study is intended to evaluate the safety of this gene therapy investigational product and assess preliminary evidence of efficacy using plasma ldl-c levels as a surrogate biomarker for human ldlr transgene expression. subjects may be asked to participate in an optional kinetics study to assess the metabolic mechanism by which ldl-c is reduced.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age. * untreated and/or treated ldl-c levels and clinical presentation consistent with the diagnosis of homozygous fh (familial hypercholesterolemia) * molecularly defined ldlr mutations at both ldlr alleles. * a baseline serum aav8 nab (neutralizing antibody) titer ≤ 1:10. exclusion criteria * unwilling to wash out of the following lipid lowering therapies for the pre-specified time period: 1. niacin \> 250 mg/day: within 6 weeks of baseline 2. fibrates: within 4 weeks of baseline 3. lomitapide: within 8 weeks of baseline 4. mipomersen: within 24 weeks of baseline * history of cirrhosis or chronic liver disease based on documented histological evaluation or non-invasive imaging or testing. * abnormal liver function tests (lfts) at screening (ast (aspartate aminotransferase) or alt (alanine aminotransferase) \> 2 × upper limit of normal (uln) and/or total bilirubin of \> 1.5 × uln

Keywords: ldl receptors gene therapy metabolic diseases rare diseases genetic diseases atherosclerosis cardiovascular disease
bgs649 monotherapy in moderate to severe endometriosis patients

Conditions: Endometriosis

Summary: this study will assess the safety and tolerability of bgs649 in women with moderate to severe endometriosis.


Eligibility criteria:
inclusion criteria: * premenopausal women with documented moderate to severe endometriosis. occurrence of three sequential menstrual cycles of 24-35 days duration prior to enrollment. * laparoscopically proven diagnosis of moderate to severe endometriosis (diagnosed within the past 10 years before screening). * patients not planning to become pregnant within one year after the screening visit and willing to use two effective methods of non-hormonal, barrier birth control for the duration of the study or who are surgically sterile. * patients must have a score of at least 4 on the numerical rating scale (nrs) for one of the following three pain measurements: pelvic pain, menstrual pain and dyspareunia exclusion criteria: * estrogen replacement therapy using either prescription medications or estrogen-containing otc nutritional/herbal supplements such as soy extracts or topical estrogens. * aromatase inhibitor therapy (includes femara (letrozole), aromasin (exemestane) or arimidex (anastrozole) within the past 12 months. * oral bisphosphonate therapy (i.e. fosamax (alendronate)) within the past 6 months or intravenous bisphosphonate (i.e., reclast, pamidronate) \< 15 months from screening. * systemic glucocorticoid therapy within the past 4 weeks. * contra-indications to oral contraceptive use. other protocol-defined inclusion/exclusion criteria may apply

Keywords: endometriosis infertility pain vaginal diseases uterine diseases
ovarian follicle function in patients with primary ovarian failure

Conditions: Amenorrhea; Hypoaldosteronism; Hypogonadism; Infertility; Premature Ovarian Failure

Summary: no proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous premature ovarian failure. we know that one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. this is a diagnostic omnibus protocol that permits baseline clinical evaluation of patients with prematurem ovarian failure. the findings will determine patients' suitability for specifically focused therapeutic research protocols.

no proven therapy to restore ovarian function and fertility is available to patients with karyotypically normal spontaneous primary ovarian insufficiency. we know that more than one-half of these patients have primordial follicles remaining in the ovary, and these follicles can function intermittently. this protocol permitted baseline clinical evaluation of patients with primary ovarian insufficiency and ongoing observation of the natural history of the disorder. the protocol is now in the follow up and analysis phase and is not now recruiting new patients. now a major aim of the protocol is to investigate large scale medical sequencing as a method by which to uncover mechanisms of primary ovarian insufficiency and to assist in the management of women with this condition. this will involve a community-based participatory research approach.

Eligibility criteria:
* inclusion criteria: women 18 to 42 years of age with primary ovarian insufficiency who meet the following requirements were candidates for recruitment to the study: 1) at least a four month history of oligo-amenorrhea not due to pregnancy, and 2) clearly elevated gonadotropins in the menopausal range on two separate occasions at least one month apart. exclusion criteria: women with evidence for karyotypic, metabolic, toxic, or iatrogenic cause of the ovarian insufficiency were not candidates.

Keywords: menopause estrogen infertility ovulation amenorrhea hypergonadotropic hypogonadism young women gonadal steroid deficiency mineralocorticoid deficiency premature ovarian failure pof
oxandrolone compared with a placebo on growth rate in girls with growth hormone-treated turner's syndrome

Conditions: Turner's Syndrome

Summary: rationale: turner's syndrome is a disease in which females are missing all or part of one x chromosome and do not produce the hormones estrogen and androgen. giving growth hormone may help girls with turner's syndrome attain a more normal height. it is not yet known if growth hormone is more effective with or without oxandrolone for turner's syndrome. purpose: randomized phase ii trial to study the effectiveness of oxandrolone in girls who have growth hormone-treated turner's syndrome.

protocol outline: this is a randomized study. patients are randomly assigned to recombinant human growth hormone (gh) and oxandrolone versus gh and placebo. gh is administered by daily subcutaneous injection and oxandrolone is given every day by mouth. treatment continues for 3 years; estrogen is offered after year 2. a study duration of 8 years is anticipated.

Eligibility criteria:
protocol entry criteria: turner's syndrome-compatible karyotype no y material in peripheral karyotype bone age no greater than 11 years --prior/concurrent therapy-- no more than 12 months of prior estrogen, androgen, or growth hormone

Keywords: turner's syndrome genetic diseases and dysmorphic syndromes rare disease
observational safety study in subjects using levemir® (insulin detemir) for the treatment of type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the gulf countries


Eligibility criteria:
inclusion criteria: * after the physician decision has been made to use insulin detemir therapy, any subject with type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. the selection of the subjects will be at the discretion of the individual physician exclusion criteria: * subjects who are unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for the final visit; * subjects currently being treated with insulin detemir; * subjects who previously enrolled in this study or studies related to novomix 30; * subjects with a hypersensitivity to insulin detemir or to any of the excipients; * women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.
clinical effect of long round needle

Conditions: Cervical Spondylotic Radiculopathy

Summary: the goal of this clinical trial is to test in the clinical effect of long round needle in the treatment of cervical spondylotic radiculopathy, and analyze its safety and its influence on pain and functional recovery. the main question it aims to answer is whether long round needle therapy for patients with cervical spondylotic radiculopathy is effective and safe. participants will be selected as the research objects. they will randomly divided into control group (n = 49) and observation group (n = 49). the control group was treated with filiform needle, and the observation group was treated with long round needle. researchers will compare the two groups to see the differences on the therapeutic effect, safety, neck dysfunction index (ndi), pain score (mcgill pain questionnaire, mpq), quality of life (generic quality of life inventory-74, gqol-74), and levels of inflammatory factors.


Eligibility criteria:
inclusion criteria: (1) meet the efficacy criteria for disease certificate diagnosis of traditional chinese medicine\[4\]in the category of "arthralgia syndrome" and "stiff neck", the main diseases: numbness and pain in the shoulder, neck and upper limbs, secondary diseases: unfavorable neck movement, hard, heavy head, thin coating, reddish tongue; (2) cervical x-ray shows hyperplasia of the vertebral body; (3) the patient or family members are informed and signed consent. exclusion criteria: (1) patients with severe periarthritis of shoulder and mixed cervical spondylosis; (2) spinal canal space-occupying lesions and cervical spine tumors; (3) serious immune system diseases and infectious diseases; (4) liver and kidney insufficiency; (5) cardiovascular and cerebrovascular diseases; (6) mental diseases or medical history; (6) patients with incomplete clinical data and poor compliance.
study to evaluate the safety and efficacy of a single dose of sti-2020 (covi-amg™) to treat covid-19

Conditions: Covid19

Summary: subjects will receive a single injection of 40, 100, or 200 mg covi-amg or placebo via iv push.

subjects will receive a single injection of 40, 100, or 200 mg covi-amg or placebo via iv push. subjects will be followed for 70 days after dosing.

Eligibility criteria:
inclusion criteria: * outpatient with recent covid-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to screening and not requiring imminent hospitalization * no medical or psychiatric conditions that could put the subject at risk * willing to follow contraception guidelines exclusion criteria: * clinical signs of covid-19 indicative of impending hospitalization * documented infection in addition to covid-19 that requires systemic treatment * medical condition that could adversely impact safety, in the investigator's opinion * is or planning to be pregnant or lactating * has participated, or is participating, in a clinical research study evaluating covid-19 convalescent plasma, monoclonal antibodies (mabs) against sars-cov-2, or intravenous immunoglobulin (ivig) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit * has received or will receive during study participation a vaccine for covid-19 * has participated in clinical trial protocols in the last 12 months, unless the investigator believes that there may be a direct benefit to the subject

Keywords: covid-19